A Field Evaluation of Five On-Site Drug-Testing Devices

Journal of Analytical Toxicology,Vol. 26, October 2002 A Field Evaluation of Five On-Site Drug-Testing Devices Dennis J. Crouch 1,*, Rebekah K. Hersch 2, Royer F. Cook 2, James F. Frank 3, and J. Michael Walsh 4 Introduction Abstract A field study was performed at two police agencies to evaluate the utility and accuracy of five on-site urine analysis drug-testing devices when used to test driving under the influence (DUI) arrestees. The devices evaluated were AccuSign| Rapid Drug Screen| TesTcup-5| TesTstik~, and Triage| Standard workplace screening cut-off concentrations were used and samples were tested for marijuana, cocaine and metabolites, amphetamine(s), opiates, and PCP (except opiates 300 ng/mL). Four-hundred arrestees were recruited at each site, informed consent was obtained, and urine specimens were collected from each subject for analysis. Police officers conducted the testing with one device, and trained technicians performed testing with the other four devices. The device used by the officers was rotated. All positive and 5% of the negative samples were confirmed in a laboratory using mass spectrometry. Laboratory cut-off concentrations were 4 ng/mL for carboxy-THC; 50 ng/mL for benzoylecgonine; 100 ng/mL for amphetamines; 50 ng/mL for opiates; and 5 ng/mL for PCP.Approximately one-third (36%) of the subjects tested positive for at least one drug. No randomly selected sample, that tested negative on the devices, tested positive at the laboratory. Based on 800 specimens, the false-negative rate for each device was < 1% for all drug classes. A false positive was defined as testing positive with the device, but the specimen did not contain detectable drug, given the study reporting criteria. For marijuana, benzoylecgonine, and opiates, all devices bad _<0.25 % false-positive rates. For PCP, the false-positive rates were all < 1.5%. For amphetamine(s), the false-positive rates were all _<1.75%. These rates were adjusted because study confirmation batteries included methylenedioxyamphetamine, methylenedioxymethamphetamine (MDMA), additional overthe-counter sympathomimetic amines, hydromorphone, and hydrocodone. Without the expanded confirmation battery, false-positive rates approached 4% (Triage) for amphetamines and were _>2.25% for opiates. Fifty to 90% of the positive amphetamine(s) samples contained MDMA. A similar percentage of the opiate-positive samples contained bydromorphone or hydrocodone. When additional drugs were included in the confirmation testing, it was concluded that the on.site urine analysis drug-testing results were useful in DUI investigations. * Author to whom correspondenceshould be addressed. Numerous studies have demonstrated that impairment by alcohol and/or drug use is a safety concern in the U.S. (1). Willette and Walsh pointed out that the full impact of drugs on traffic safety was unknown in the early 1980s and, unfortunately, this remains true today (2). However,data have emerged that provide some insight into the extent of the problem. For example, Williams et al. (3) reported that in a "high risk" sample of 440 young male auto drivers killed in California traffic accidents, 70% of blood specimens contained alcohol, over 40% contained other drugs, 37% contained cannabinoids, and 11% contained cocaine. Soderstrum et al. (4) found that of 1023 patients admitted to The Maryland (Baltimore) Shock and Trauma Unit, 34.7% had very recently used marijuana (i.e., > 3 ng/mL tetrahydrocannabinol in serum) and 33% had blood-alcohol concentrations (BAC) > 0.10% (w/v).The Lund et al. (5) study of 300 paid volunteer truck drivers randomly selected at an interstate weigh station demonstrated that 29% were positive for drugs. Comparatively little data have been published on the prevalence of drugs in drivers detained by the police for erratic driving. Compton and Anderson (6) reported that the prevalence of drugs in arrested drivers with BACsbelow 0.10% (w/v) was between 14% and 50%. The most frequently encountered drugs in order of prevalence were marijuana, tranquilizers and sedatives, hallucinogens (PCP), cocaine, amphetamines, and opiates. In the Virginiaportion of the study, blood from 788 drivers was tested, and 16% of the samples contained one or more drugs. A six-year Californiastudy reviewedby the authors showed annual prevalence rates of 30% to 50% for drugs in arrested drivers (6).A second Californiastudy reviewedby the authors showed that between 14.4% and 23% of the blood samples collected from impaired drivers contained marijuana (6). Recently, on-site drug-screening devices have been introduced for urinalysis drug testing (7,8). These devices are commercially available, immunoassay based, require no sophisticated instrumentation, and do not require a permanent laboratory or extensively trained personnel. Several studies Reproduction(photocopying)of editorialcontentof thisjournalis prohibitedwithoutpublisher'spermission. 493 I Center for Human Toxicology, University of Utah, 20 South 2030 East, Room 490, Salt Lake City, Utah 84112; 21SAAssociates, 201 N. Union Street Suite 330, Alexandria, Virginia 22314; 3National Highway Traffic Safety Administration, 400 7th Street, SW, NTS -1 I, Washington, D.C 20590; and 4The Walsh Group, 6701 Democracy Blvd., Suite 300, Bethesda, Maryland 20817 Journal of Analytical Toxicology, Vol. 26, October 2002 Methods Identification of devices Several commercially available on-site devices were considered for inclusion in the study. To be seriously considered, the device manufacturer had to be a stable business entity, responsive, and able to provide the devices expeditiously. The manufacturer-recommended procedures were reviewed for simplicity, analysis time, number of reagents, number of testing steps, stability of the test results, and applicability for use by non-technical analysts. Practical issues were considered such as storage requirements, shelf life, special requirements for disposal, and the need for additional supplies and materials. The scientific literature was reviewed to assess the accuracy and reliability of the devices based on published studies. The following deviceswere selected: AccuSign (Princeton Biomedical Corp., Princeton, NJ), OnTrak TesTcup-5 (Roche Diagnostic Systems, Inc., Indianapolis, IN), OnTrakTesTstik (Roche Diagnostic Systems, Inc.), Rapid Drug Screen (American Bio Medica Corp, Ancramdale,NY),and Triage (Biosite Diagnostics, San Diego, CA). The cut-off concentrations for the devices were consistent with the federal recommendations and are shown in Table I (20,21). 494 Site selection and on-site testing After considering several potential sites for the study, Houston, TX and Nassau County,NYwere selected (19). Fourhundred subjects were recruited per site. Staff from ISA Associates (ISA)and the Center for Human Toxicology(CHT) trained all officers and the research analysts in the use of the devices. Manufacturers were also encouraged to contact the sites a (...truncated)